Vitamin D Supplementation and Pregnancy Outcomes

T

Tirang R. Neyestani, Ph.D.

Status

Completed

Conditions

Maternal Vitamin D Status

Treatments

Dietary Supplement: Vitamin D3 (2000 IU)
Dietary Supplement: vitamin D3 (1000 IU)

Study type

Interventional

Funder types

Other

Identifiers

NCT03308487
IR.SBMU.RETECH.1395.631

Details and patient eligibility

About

Groups (group 1 receives 1000 IU vitamin D and group 2 receives 2000 IU vitamin D) through a random allocation. It is necessary to mention that all cases in each group could be able to receive the current supplementation during pregnancy (Folic acid, iron and multivitamin and calcium). This study aimed to evaluate the efficacy of two doses of vitamin D supplementation (1000 and 2000 IU/d) during pregnancy on maternal and newborn vitamin D status and metabolic profile including lipid profile (serum concentration of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglyceride(TG)), glucose homeostasis (fasting glucose, insulin, insulin resistance (HOMA-IR)) and inflammatory and oxidative stress (OS) markers and pregnancy outcomes including gestational diabetes, preeclampsia, preterm delivery, abortion, cesarian section, and also anthropometric data and apgar score of infants compared with placebo.

Full description

In this randomized controlled trial, 84 pregnant women aged at 18-40 years with gestational age of <12 weeks will be recruited and divided into 2 groups. Demographic, socioeconomic and lifestyle data as well as blood samples and urine samples will be collected at baseline and in the last month of pregnancy. Moreover the cord blood will be collected at birth. Fasting blood glucose, insulin resistance (HOMA-IR), insulin, lipid profile (serum concentration of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglyceride(TG)), inflammatory (IL-1β, IL-6, TNF-α, hs-CRP) and oxidative stress markers (MDA, TAC), calcium:creatinine ratio are going to be evaluated at the beginning and in the end of the interventional period in pregnant women. Inflammatory (IL-1β, IL-6, Tumor Necrosis Factor (TNF-α), hs-CRP) and oxidative stress markers (MDA, TAC) will be determined in cord blood as well.

Enrollment

84 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • maternal age of 18-40 years,
  • gestational age of 12 weeks or less,
  • singleton pregnancies,
  • mothers supposed to have normal pregnancy and not having preexisting diseases like hypertension, or cardiac, renal, hepatic, autoimmune , rheumatoid arthritis and digestive disease, or endocrinological disorders including diabetes (type 1 or type 2 diabetes), parathyroid disorders, and thyroid disorder,
  • not receiving dietary supplements including vitamin D (>600 IU/d), or omega-3 within the past 3 months before the intervention,
  • not taking medications that could potentially influence vitamin D metabolism,
  • willingness to participate in the study.

Exclusion criteria

  • Participants who do not meet the inclusion criteria,
  • those who diagnosed to have fasting blood sugar (FBS)>92 at first blood sampling and/or blood pressure > 140/90 mmHg at the first visit,
  • using extra vitamin D3 supplement and/or omega-3 and/or other medications that could potentially influence vitamin D metabolism,
  • fetal anomaly,
  • poor adherence to the study protocol,
  • unwillingness to continue the intervention.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

84 participants in 2 patient groups

vitamin D3 (1000 IU)
Active Comparator group
Description:
group 1
Treatment:
Dietary Supplement: vitamin D3 (1000 IU)
vitamin D3 (2000 IU)
Active Comparator group
Description:
group 2
Treatment:
Dietary Supplement: Vitamin D3 (2000 IU)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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